Immunologic Response to Inactivated Vaccine for Novel H1N1 Virus (NCT01023711) | Clinical Trial Compass
CompletedNot Applicable
Immunologic Response to Inactivated Vaccine for Novel H1N1 Virus
United States107 participantsStarted 2009-11
Plain-language summary
The purpose of this study is to describe the immune response to a novel H1N1 influenza vaccination in healthy adults, and to understand the factors that allow healthy adults to respond to a single dose of vaccine even if they have never previously experience novel H1N1 disease or vaccination.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Aged 18-32 years, or 60 years and older
* No history of Novel H1N1 virus or vaccine
* Female not able to bear children or not pregnant and agrees to practice effective birth control
* Female negative pregnancy test
* Good Health
* Ability to understand and comply with protocol
* Provided Informed Consent
Exclusion Criteria:
* Previous history of vaccination against novel H1N1 or laboratory documented H1N1 infection
* Previous history of vaccination with A/New Jersey/76 vaccine (for subjects 60 \& older
* History of egg allergy or is allergic to other components of the vaccine
* Women who are pregnant or breastfeeding or intends to get pregnant during the study period between enrollment \& 30 days following vaccination
* Subject is immunosuppressed as the result of underlying illness or treatment with immunosuppressive or cytotoxic drugs or use of chemotherapy/radiation therapy in the preceding 36 months
* Subject has active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematological malignancy. "Active" is defined as treatment within the past 5 years.
* Long term (greater than 2 weeks) use of oral or parental steroids, or high- dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal \& topical steroids allowed)
* Received immunoglobulin or other blood product within 3 months prior to enrollment in th…